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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH OSSEOSPEED EV 3.0 S - 15 MM; IMPLANT, ENDOSSEOUS, ROOT-FORM
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DENTSPLY IMPLANTS MANUFACTURING GMBH OSSEOSPEED EV 3.0 S - 15 MM; IMPLANT, ENDOSSEOUS, ROOT-FORM Back to Search Results
Catalog Number 25216
Medical Device Problem Codes Off-Label Use (1494); Failure to Osseointegrate (1863)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 06/05/2024
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.No information besides implant failure and catalog number was received so far.Additional information and product return is requested.Follow-up report will be sent in case additional information will be received.Trend is tracked and monitored.
 
Event or Problem Description
It was reported that a patient experienced a dental implant loss.
 
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Brand Name
OSSEOSPEED EV 3.0 S - 15 MM
Common Device Name
IMPLANT, ENDOSSEOUS, ROOT-FORM
Manufacturer (Section D)
DENTSPLY IMPLANTS MANUFACTURING GMBH
rodenbacher chaussee 4
hanau hessen 63457
GM  63457
Manufacturer (Section G)
DENTSPLY IMPLANTS MANUFACTURING GMBH
rodenbacher chaussee 4
hanau hessen 63457
GM   63457
Manufacturer Contact
dan eagar
221 west philadelphia st.
york, PA 17401
7178457511
MDR Report Key19790479
Report Number3013111692-2024-21619
Device Sequence Number7096728
Product Code DZE
UDI-Device Identifier07392532132476
UDI-Public07392532132476
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K120414
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2024
Device Explanted Year2024
Reporter Type Manufacturer
Report Source Foreign,Health Professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 07/19/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Catalogue Number25216
Device Lot Number432857
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date06/26/2024
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/26/2024
Initial Report FDA Received Date07/22/2024
Was Device Evaluated by Manufacturer? (Y/N) No
Usage of Device A
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
25298-502577
Outcome Attributed to Adverse Event Required Intervention;
Patient SexUnknown
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